The following data is part of a premarket notification filed by Orthoaccel Technology Inc. with the FDA for Acceledent Optima.
| Device ID | K170093 |
| 510k Number | K170093 |
| Device Name: | AcceleDent Optima |
| Classification | Orthodontic Vibratory Accessory |
| Applicant | OrthoAccel Technology Inc. 6575 West Loop South, Suite 200 Bellaire, TX 77401 |
| Contact | Jouana Harris-livings |
| Correspondent | Jouana Harris-livings OrthoAccel Technology Inc. 6575 West Loop South, Suite 200 Bellaire, TX 77401 |
| Product Code | OYH |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-11 |
| Decision Date | 2017-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852673007240 | K170093 | 000 |